Stroke Program Clinical Trials

MISTIE III: A phase III, randomized, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage.Aims: The purpose of this study is to determine the safety and effectiveness of an emergency treatment for intracerebral hemorrhage (spontaneous bleeding in the brain) as compared to current standard of care. The investigational treatment involves a procedure to remove the blood clot in the brain through a small tube, and the use of a drug called rt-PA, to break up the clot and further aid in its removal. Study participants will be randomly assigned to either the investigational treatment or current standard of care, which does not include removal of the clotPrincipal Investigator: Shakeel Chowdhry, MDIRB Approval Number: EH13-028Funding Source: Johns Hopkins University/The National Institute of Neurological Disorders and Stroke (NINDS)Contact: Please call 847.570.4224 with questions regarding the studyOpen to Enrollment: Yes

SOCRATES – Acute Stroke Or Transient Ischaemic Attack Treated with Aspirin or Ticagrelor and Patient Outcomes TrialA Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events with Ticagrelor Compared to Aspirin (ASA) in Patients with Acute Ischaemic Stroke or TIAAims: To compare the effect of 90-day treatment with ticagrelor (180mg loading dose on Day 1 followed by 90mg twice daily for the remainder of the study) vs aspirin (300mg loading dose on Day 1 followed by 100mg once daily for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction and death) in patients with acute ischaemic stroke or TIA when initiated within 24 hoursPrincipal Investigator: Rima Dafer, MD, MPHIRB approval number: EH13-430Funding source: Astra ZenecaContact: Please call 847.503.4322 with questions regarding the studyOpen to enrollment: Projected March 2014

Humanitarian Use Device: Wingspan Stent System with Gateway PTA Balloon CatheterAims: This device is used to increase cerebral artery blood flow in patients with intracranial atherosclerotic disease; a stent is placed in the effected area and is deployed by inflation of a very small balloon, which widens the occluded vessel Principal Investigator: Hamad Farhat, MDIRB Approval Number: EH12-355Funding Source: Manufacturer: Stryker NeurovascularContact: Please call Robert Frech at 847.570.4224 with questions regarding the deviceOpen to Enrollment: Yes - patients are being treated with this device

Note: Humanitarian Use Devices

Humanitarian Device Exemption OverviewAn Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations. An approved HDE authorizes marketing of the HUD. However, an HUD may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease. The labeling for an HUD must state that the device is an humanitarian use device and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been demonstrated.